An interventional study of Condom in Performance of Synthetic Polyurethane Male Condom, sponsored by Okamoto Industries, Inc.. Terminated at 4 sites in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-20.
Sponsored by Okamoto Industries, Inc. · Not applicable, Interventional, and Prevention
This study is a randomized, double-blinded, crossover and multi-center study to evaluate the clinical breakage and slippage of a new synthetic polyurethane male condom compared to a commercially available standard latex condom.
This study is a randomized, double-blinded, crossover and multi-center study to evaluate the clinical breakage and slippage of a new synthetic polyurethane male condom compared to a commercially available standard latex condom.
The duration of participation for each couple is approximately 6 weeks. Study subjects are given a set of one condom type to use for up to three consecutive weeks to complete each evaluation and then return for a set of the other condom type for another period of up to three weeks of evaluation.
The primary objective of this study is to determine whether the total clinical failure rate of a new test condom is comparable with the total clinical failure rate of a legally marketed latex condom when used during vaginal intercourse.
The secondary objective of this study is to evaluate the clinical slippage and breakage of the polyurethane and latex condoms, as well as user acceptance about using the devices and adverse events.
This is the only study on the registry with Okamoto Industries, Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Subjects are required to meet ALL of the following criteria for randomization into the study:
l) willing to use the study products for minimum of 10 acts of vaginal intercourse within 6 weeks of study entry; l) willing and capable of following requirements of protocol, including willingness to respond to questions about reproductive and contraceptive history and use of condoms during interviews; m) agree to use and has internet/web access in order to complete the Diaries and Surveys using iMedNet's ePRO module; n) available for follow-up and reachable by telephone.
Exclusion Criteria:
Subjects will be excluded in ANY of the following exclusion criteria apply at the time of entry or at the time during the study. If either partner is (or becomes) aware that:
The test device name is Okamoto 001 Lubricated Polyurethane Male Condom. The condom is made in Japan and conforms to ASTM D6324-11 (2017) Standard Test Methods for Male Condoms Made from Polyurethane.
Device: Condom
Commercially available latex lubricated condom.
Device: Condom
Contraception
The total clinical failure rates for the test and control condoms
The total clinical failure rate of a new test condom is comparable with the failure rate of a commercially available latex condom when used during vaginal intercourse as reported by study participant questionnaire.
Time frame: 6 weeks
Clinical / Non-clinical slippage rates acceptability; and Adverse events
Evaluate the slippage rates of the polyurethane and the commercially available latex condom when used during vaginal intercourse, as reported by the study participant questionnaire.
Time frame: 6 weeks
Clinical/non-clinical breakage rates
Evaluate the breakage rates of the polyurethane and the commercially available latex condom when used during vaginal intercourse, as reported by the study participant questionnaire.
Time frame: 6 weeks
User acceptance
Evaluate the user acceptance rates of the polyurethane and the commercially available latex condom when used during vaginal intercourse, as reported by the study participant questionnaire.
Time frame: 6 weeks
Adverse events
Evaluate the number of adverse events of the polyurethane and the commercially available latex condom when used during vaginal intercourse, as reported by the study participant questionnaires and study Primary Investigators.
Time frame: 6 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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